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Clinical Data Coordinator Resume Samples
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0-5 years of experience
Expertly reviewed Case Report Form and data for completeness, compliance, accuracy and consistency with all applicable procedures.
- Issued queries to sites, generated medical coding queries; updated Oracle & Medidata RAVE databases upon resolution.
- Performed listing reviews, AE-SAE reconciliation.
- Successfully trained Site Coordinators for proper understanding of DM concepts, mentored new team members, performed Peer Review.
- Evaluated and revised SOP’s – Data Handling Conventions, Manual Review & Listing Review to reflect current discrepancy management practices, updated and authored CRF completion guidelines.
- Initiated Quality Reviews, identified all issues and proposed resolution. Performed Data Access Testing and User Access Testing (UAT) to ensure accuracy of the database.
- Resolved issues within Oracle database & data entry group, created patient recordin Oracle Clinical.
0-5 years of experience
Responsible for form design, database setup, daily project maintenance and data review for projects using new technologies and different data management platforms, including Oracle Clinical 3.1.1 and FaxCollect.
- Worked regularly with SAS and Oracle programmers to develop and revise edit checks and listing output to ensure clean data.
- Successfully managed and supervised database audits, while complying with contractual quality control plans.
- Streamlined costs by managing project budgets.
- Delegated responsibility to help work through aggressive timelines.
- Assured Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Served as an integral role to the collection of metric information needed to accurately price the system and provided meaningful information for marketing and business development efforts.
0-5 years of experience
Super-User/company Trainer of SBHG’s instated Business Intelligence Software and Dashboard.
- Project managing skills helped place SBHG’s BI integration ahead of scheduled annual deadline.
- Facilitated communication, coordination and trouble-shooting between research staffs, programmers, IT/EMR consultants for design and implementation of a Business Intelligence/Analytics system.
- Maintained multiple quality assurance records checks that increased agency profits due to lowered held claims.
- Ran mental health business analytics for SBHG’s statewide agency.
- Managed data of all electronic medical records utilized for business intelligence.
- Worked as a Liaison between agency Electronic Medical Record staff, IT and the research department.
0-5 years of experience
Achieved first and second pass medical data entry with greater than 99% accuracy.
- Worked on multiple studies with separate and distinct data handling rules.
- Reviewed data management plans for multiple clinical studies for pre-market implantable cardiac devices.
- Assisted in database conversion and helped verify accuracy and completeness of data from one database to another.
0-5 years of experience
Utilized the legacy information system, Meditech, and Report Writer to extract and compile reports for hospital administration team.
- Developed collection and analysis tools using VBA in Excel linked by ODBC to SQL Server, moving the extracted data into an OracleXE repository for manipulation using SQL and PL/SQL stored procedures, to supplement record sets not existing in legacy system.
- Worked with various departments to make improvements on the data collection process and reeducate users to improve the quality of data.
- Handled ad-hoc reporting requests and provided data for trending / analysis for strategic meetings
- Created and implemented an oncology application using Excel and VBA after researching more costly external solutions, and saved the hospital $200,000.
0-5 years of experience
Data Entry from the Case Report Forms (CRF) and forwarded it to the Manager for Validation
- Ensured completeness, accuracy and consistency of the data so that it meets the standards of quality expected for reporting to regulatory bodies while following Good Clinical Practices (GCP).
- Designed and approved forms (CRF) on which Data were to be collected.
- Produced summary listings of safety and efficacy data for health interventions.
- Tested new systems and processes for the management of clinical trials.
0-5 years of experience
Conducted data review for inconsistent, illogical or inaccurate data
- Reviewed protocols, standard operating procedures (SOPs) and validation guidelines
- Generated queries and updated the database with resolutions
- Participated in close-out activities and database finalization
- Provided training and skill development for new temporary staff.
- Performed 30 day, 3-month and 6-month reviews to determine employment status
- Reviewed completed tasks for each temporary employee (responsible for up to 5 temp employees) and assessed additional needed skills
0-5 years of experience
Collected, reviewed and submitted clinical data required for Bone marrow clinical trial.
- Maintained electronic donor medical history and follow up records in the donor center and registry databases.
- Managed timely and accurate entry of data into registry databases.
- Implemented a new approach of reporting and collecting protocol deviation and adverse events reports.
- Coordinated periodic internal audits of Request Management donor files.
- Educated coordinators regarding appropriate and accurate data necessary to report adverse events and protocol deviations.
0-5 years of experience
Reviewed patient data for completeness and accuracy prior to entering into database.
- Resolved and reviewed systematic and manual data discrepancies.
- Assisted in the initial and ongoing data related training for current and new associates within Clinical Data Management.
- Assisted Database Developers in the implementation and maintenance of existing databases.
- Participated in database development and testing, and maintained detailed records of work performed.
- Utilized Oracle Clinical 4.5 and Teleform Elite.
- Reviewed case report forms generated from clinical trials for completeness and accuracy using edit check procedures, case report form listings, manual review and other appropriate guidelines.
0-5 years of experience
Provided customer service to consumers, health care professionals, and internal client personnel.
- Complete appropriate documentation of databases and project files according to project guidelines.
- Reviewed queries generated and resolved by other team members
- Performed database checks following specified guidelines and applicable SOPs/working documents.
- Performed database transfers/uploading into database.
- Performed routine quality control checks as specified in study QC plan
- Assisted in maintaining data management binder and identified process changes to work instructions
0-5 years of experience
Performed duties related to editing and preparing clinical data for analysis. As clinical data coordinator utilized database software, Excel and proprietary software to summarize research projects.
- Supervising of data entry staff.
- Trained and managed incoming data entry operators.
- Ensured the accuracy and constancy of clinical data.
- Independently reviewed and resolved discrepancies in clinical data in conjunction with Project Directors, Site Monitors and other data management staff.
- Created and maintained uniform and standardized policies which meet Good Clinical Practice (GCP) standards.
- Responsible for the data management activities of at least two protocols at time.
- Assisted in developing strategies for eCRF/CRF design and data collection methods.
0-5 years of experience
Coordinated Data Management tasks from protocol review to database lock for assigned studies.
- Assessed and assured the quality and consistency of data generated from clinical trial programs.
- Audited database contents against clinical case report forms (CRFs) and corrected any discrepancies.
- Reviewed CRFs, generated and tracked data correction/queries.
- Recommended intermediate and short-terms target dates for all projects and provided weekly status reports.
- Designed, ordered, tracked and proofed CRF workbooks and coordinated target dates with printing services.
- Assisted in the coordination of services provided by eternal data management vendors or contract research organizations.
- Attended some initiation visits, closeout visits, site coordinator and nurse coordinator meetings.
0-5 years of experience
Worked independently with team members in clinical operations and clinical programming to resolve straightforward study issues
- Worked closely with LDM to identify and resolve complex study issues
- Represented Data Management in internal team meetings in LDM’s absence
- Managed local lab normal ranges for both U.S. and International sites
- Reviewed discrepancies in Oracle Clinical 4.5
- Created and updated Data Clarification Forms (DCF) in Oracle Clinical 4.5
- Reviewed focus listings and issued DCFs based on findings
- Performed Quality Control/Check (QC) audits and resolving issues discovered during audits.
0-5 years of experience
Managed workflow between study sponsor, monitors, data-entry operators, and clinical
data coordinators
- Tested data-entry screens; suggested changes if necessary
- Trained and supervised data entry and coordinator in Oracle Clinical
- Generated and resolved data queries and updates
- Interacted closely with clinical team regarding database updates
0-5 years of experience
Managed database for a multicenter study on platelet transfusion in preterm neonates
- Reviewed, verified and validated collected data
- Ensured accurate entry of data into the study database
- Resolved data queries accurately and within study specific timeframes
- Participated in project meetings to give status update to the P.I.
0-5 years of experience
Identified and resolved administrative issues with clinical trial investigator sites and safety team management
- Evaluated clinical trial safety reports for completion according to client safety reporting guidelines.
- Verified safety reports were entered into client tracking database and assigned for processing with the appropriate priority status.
- Performed quality checks of safety data entered into client safety database, making updates and corrections as needed.
- Assisted with data entry and project support responsibilities as needed.
0-5 years of experience
Served as a Data Operations Coordinator on multiple global studies providing leadership to multiple team members
- Performed validation of computerized edits, SAS listings and Custom Reports and provided input on development of edit specification document
- Quality Review oversight and training/retraining of team members
- Managed the delivery of projects through the full data management process including the database lock of 4 global studies
- Developed and maintained good working relationships with the operations team
- Assist with the management of project timelines
- Communicated ideas and solutions to the project team
- Served as a Lead Data Manager, as needed
0-5 years of experience
Performed 1st and 2nd entry of clinical trial data and database changes as directed by management
- Created queries to send to sites, closed returned queries
- Reviewed and addressed quality control findings
- Processed and updated Serious Adverse Event data & MACE; processed and signed Adjudication Forms
0-5 years of experience
Created and provided monthly, weekly, and quarterly data reports to monitor differing clinical, financial, and trending data.
- Tracked and trended data to provide useful metric information to the company community for quality improvement.
- Assisted with maintenance and updating of company websites that provided weekly updated data to the Clinical Operations team.
- Maintained and updated data of multiple varying metrics to provide information for quality improvement specific to regional areas.
- Coordinated and maintained data from varying departments to track and trend into a collaborative reporting system.
- Identified and communicated trends/issues from weekly indicator reports to Director of Operations, Area Vice Presidents, Vice Presidents, and Senior Leadership as necessary.
0-5 years of experience
Developed and implemented DM guidelines, CRFs, validation specification, database specifications, timelines, and tracking tools
- Led DM team through the cleanfile efforts resulting in database lock
- Conducted meetings, and trained new data management and monitoring team members
- Organized and monitored data cleaning efforts including SAE reconciliation
- Presented query process and DM guidelines at Investigator’s meetings
- Represented project in project meetings and acted as liaison to return information full project team
0-5 years of experience
Planned and executed projects to meet detailed project timelines, cost, quality, and customer satisfaction.
- Monitored and coordinated the production, maintenance and operation of the project.
- Assisted with site monitoring questions, and investigator training activities as needed.
- Generated, tracked and resolved data clarification, Lab and SAE Reconciliation queries.
- Lead a team of 5 in Records Management, Data Analyst and Data Processors.
- Assisted with activities involving Transfer of data to the client.
- Validation Screen Testing/Writes Test Data.
0-5 years of experience
Responsible for the review and audit of all database queries, ensuring 100 percent accuracy
- Adhered to study lock and interim analysis timelines for successful completion of assigned tasks
- Partnered with clinical operations and data management to develop internal project plans
- Interfaced with sponsors, vendors and on-site staff to complete shared objectives and training
- Built and repaired queries in both EDC and SAS databases to provide dependable and concise reporting
- Designed and maintained spreadsheet templates necessary for reporting, tracking and updating pertinent laboratory and sponsor data
- Collaborated with system program developers to ensure optimum database performance and reporting
- Responsible for study start up activities to include collection and review of regulatory documents, training of physicians and study coordinators, frequent entry of site contact and follow up, resolution of situations with a personable and helpful attitude
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[Clinical Data Coordinator]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
